SOP for Calibration of Polarimeter in Pharma : Pharmaceutical Guidelines

SOP for Calibration of Polarimeter in Pharma

Standard operating procedure to calibrate the Polarimeter.

1.0 OBJECTIVE

To calibrate the equipment for reliable and accurate results.

2.0 SCOPE

This procedure is applicable to the Polarimeter, installed in API Quality Control Lab.

3.0 RESPONSIBILITY

3.1 Doing: Technical Assistant
3.2 Checking: Executive /Manager

4.0 ACCOUNTABILITY

Head of the Department

5.0 PROCEDURE

Frequency: Once in a three month
5.1 Operate the instrument as per SOP.
5.2 Prepare 10%, 20%, 30%, 40% and 50% w/v aqueous solution of AR grade sucrose (previously dried) in purified water.
5.3 Note the temperature of the solution and determine the optical rotation three times by changing the solution in tube and record the mean.
5.4 Calculator corrected Optical Rotation at 20°C (a 20) using following formula.
                            at   
             a 20 =--------------
                       1+ k(t-20)
Where
a 20 = Optical rotation to be corrected at 20°C
at = Optical rotation to be corrected at t°C
t = Temperature measured by the sensor
k = Temperature correction factor (-0.00045)
5.5 Record the value in Annexure I, if it is out of limit, follow the S.O.P.

6.0 ABBREVIATIONS

6.1 % = Percentage
6.2 w/v= weight by volume
6.3 °C=Degree centigrade
6.4 API=Active Pharmaceutical Ingreadent





Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of Pharmaceutical Guidelines, a widely-read pharmaceutical blog since 2008. Sign-up for the free email updates for your daily dose of pharmaceutical tips.
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